From initial concept through regulatory approval, we provide the testing infrastructure and expertise your medical device needs. GLP compliant studies. ISO 10993 biocompatibility. FDA submission support.
Whether you need exploratory feasibility studies or formal GLP testing for FDA submission, we design protocols that answer your specific questions efficiently.
Protocol design for non-GLP and GLP studies. FDA Q-Sub (Presubmission) planning that addresses reviewer concerns before you submit. Federal grant application support that strengthens your scientific approach.
Good Laboratory Practice (GLP) studies conducted under 21 CFR Part 58. These studies generate the data FDA requires for Class II and Class III device submissions. Full regulatory compliance with quality assurance oversight.
Exploratory and proof of concept studies that inform your development strategy. These studies help you understand device performance, optimize designs, and identify potential issues before committing to formal GLP validation.
ISO 10993 compliant biocompatibility evaluation. We assess how your device interacts with biological systems, from acute cytotoxicity to chronic implantation response. Testing that satisfies FDA biocompatibility requirements.
Board certified veterinary pathologists evaluate tissue response to your device. Standardized scoring systems. Detailed histopathological analysis. Photography and digital imaging that documents findings clearly for regulatory reviewers.
Strategic guidance for FDA submissions. We help you determine the right regulatory pathway, design studies that generate defensible data, and prepare documentation that satisfies reviewer expectations.
Our facility maintains the certifications and compliance standards that regulatory reviewers expect.
United States Department of Agriculture registration ensures our animal care program meets federal standards for research facilities.
Association for Assessment and Accreditation of Laboratory Animal Care International accreditation demonstrates our commitment to the highest standards of animal welfare.
Office of Laboratory Animal Welfare assurance (PHS Animal Welfare Assurance) required for NIH-funded research and federal grant applications.
Good Laboratory Practice compliance under 21 CFR Part 58 with independent Quality Assurance Unit oversight for regulatory submissions.
Trusted Standards & Partnerships
Four decades of cardiovascular and medical device expertise. We understand what FDA reviewers expect because we've been generating the data they rely on since 1984.
Both 510(k) and PMA pathways. We design studies that generate defensible data and prepare documentation that satisfies reviewer expectations.
Founded by Duke cardiologists. Clinical perspective that informs better study design and more relevant endpoints for your device.
Medical device development is complex. Regulatory pathways are confusing. Requirements keep changing. We help you cut through it, designing studies that answer FDA's questions while keeping your timeline on track.
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